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Statistic Data Evaluation

Statistical Evaluation

Regardless of whether one's requirement is clinical studies of phases I to IV, data collection in the drug application research or drug epidemiology, or analyses from existing data sets - we will find the answers to your questions in the field of statistics.

Analysis of existing data
Study concept
Study protocoll / SAP
Support of the study conduct
Validation
Performance of the statistical analysis

Special requirements and complex statistics

In a complex world of regulatory requirements and study-specific approaches, we endeavor to provide solutions that work, even for special situations. The scenarios here range from adaptive study designs to complex evaluation approaches. According to our corporate values, this service also includes the open and comprehensively supervised integration of external expertise, in particular through cooperation with our long-standing partners.

We will find the right answers on your statistics questions.
Mr. Wedemeyer is at your disposal.

Meet us at 5th GBHI conference

Do not miss the 5th Global Bioequivalence Harmonization Initiative (GBHI) conference – the updated program is really promising.

The workshop will be held in September 2022 as a face-to-face event in Amsterdam, The Netherlands, with strong international participation. Mehul Mehta (FDA) and Barbara Schug (SocraTec R&D) will be the co-chairs for this conference, which is scheduled for September 28 and 29, 2022.

The updated program is available online here and covers the following topics:

  • Fed vs. fasted studies for immediate release dosage forms: relevance of excipients, disintegration/dissolution specificities, drug substance properties and physiological GI conditions – new findings shall help achieve harmonisation
  • Statistical considerations for BE assessment: replicate design for BE of Highly Variable Drugs, two-stage design and PK modelling as supportive tools for BE assessment
  • Topical products: Scientifically-based approaches for a waiver of clinical endpoint trials
  • Narrow therapeutic index drugs: study design and acceptance criteria



This conference is held by EUFEPS in collaboration with AAPS, supported by the European Medicines Agency (EMA) as well as the U.S. Food and Drug Administration (FDA).

In the last years this series of workshops always provided a forum for pharmaceutical scientists from academia, industry and regulatory agencies to have open discussions on selected BE issues in the hope of identifying common ground and arriving at a harmonized view on these topics.

Since we know that several of our partners and customers appreciated the interesting presentations and discussions, attending these conferences during the last years, we wanted to share the new dates and the updated program with you.